Verismo Therapeutics Treats First Follicular Lymphoma Patient in CELESTIAL-301 Trial, Strengthening Collaboration with IFLI

02.10.25 14:00 Uhr

PHILADELPHIA, Oct. 2, 2025 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, today announced that it has treated the first patient with follicular lymphoma (FL) in its CELESTIAL-301 Phase 1 clinical trial of SynKIR™-310. This milestone reflects Verismo's commitment to addressing the urgent unmet medical need for patients with FL and further strengthens the company's collaboration with the Institute for Follicular Lymphoma Innovation (IFLI).

(PRNewsfoto/Verismo Therapeutics)

CELESTIAL-301 is a multicenter Phase 1 trial (NCT06544265) evaluating the safety, tolerability, and preliminary efficacy of SynKIR™-310 in patients with relapsed/refractory B cell non-Hodgkin lymphomas (B-NHL), including FL. The study is enrolling both patients who have relapsed after prior CAR T therapy as well as those who never received CAR T treatment.

SynKIR™-310 combines Verismo's proprietary KIR-CAR platform with a new CD19 binder, which was developed by the University of Pennsylvania (Penn) under a sponsored research agreement between Penn and Verismo and exclusively licensed to Verismo, to target malignant B cells. Preclinical studies indicated that the KIR-CAR technology may extend T cell persistence, offering the potential to reduce relapse rates. The trial design includes 2 cohorts with dose escalation and an expansion cohort at the recommended Phase 2 dose.

"Treatment of the first FL patient in CELESTIAL-301 is an important milestone in the development of a CD19-directed KIR-CAR therapy and underscores the strength of our relationship with IFLI," said Dr. Bryan Kim, co-founder and CEO of Verismo Therapeutics. "We appreciate IFLI's commitment and expertise, which are helping us advance SynKIR™-310 for individuals in urgent need of new options."

In January 2025, Verismo announced a strategic investment from IFLI of up to $4.05 million to support the SynKIR™-310 FL program, enabling expanded FL-focused clinical sites to increase FL patient enrollment.

"Treating the first FL patient in CELESTIAL-301 is an important step toward delivering next-generation cell therapies to this underserved patient population," said Michel Azoulay, MD, MBA, Chief Medical Officer of IFLI. "We are proud to work with Verismo to accelerate the development of SynKIR™-310 for follicular lymphoma."

About the Institute for Follicular Lymphoma Innovation

The Institute for Follicular Lymphoma Innovation (IFLI) is a global, non-profit, private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma (FL). IFLI supports cutting-edge research and technology to lead to the development and commercialization of novel therapeutics and/or biomarkers for the treatment of FL, and to understand the biology of FL. The foundation deploys its budget across grants, project-based partnerships, and venture philanthropic investments to achieve its innovation goals. IFLI promotes collaboration and works to enable data sharing and the exchange of knowledge and expertise among researchers and institutions advancing FL research. Learn more at www.i-fli.org

About Verismo Therapeutics

Verismo Therapeutics, a subsidiary of HLB Innovation, is a pioneer in multi-chain KIR-CAR technology, with assets SynKIR™-110 and SynKIR™-310 currently in Phase 1 clinical trials. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell derived receptor and DAP12 pairing, designed to improve T cell functional persistence and reduce exhaustion, resulting in improved efficacy against challenging tumors. The KIR-CAR platform technology was developed specifically to address areas of high unmet medical need, including advanced solid tumors and B cell associated disorders and malignancies. For more information, visit: www.verismotherapeutics.com

About the KIR-CAR Platform

The KIR-CAR platform is a multi-chain CAR T cell therapy that has shown highly effective prolonged solid tumor treatment in otherwise CAR-resistant preclinical animal models with challenging tumor microenvironments.  Using NK cell derived KIR and DAP12 split signaling provides a novel paired activation and co-stimulation separate from the usual T cell stimulation pathways. KIR-CAR enables sustained chimeric receptor expression with improved long-term CAR T cell function and decreased T cell exhaustion. This results in CAR T cell resistance to tumor immunosuppression, prolonged functional persistence and improved tumor elimination. Together, this platform provides the potential for improving CAR T treatment in both solid and hematologic tumors.

Forward Looking Statements

This press release contains forward-looking statements, including, but are not limited to, those statements regarding our expectations for the timing, progress, and results of clinical trials; potential regulatory approvals; anticipated benefits, safety, and efficacy of our product candidates; our product development strategies; and other statements that are not historical facts. These forward-looking statements are based on our current expectations and are subject to numerous risks and uncertainties that could cause actual outcomes to differ materially. Important factors that could cause actual results to differ include, among others, risks related to clinical trials, regulatory processes, market acceptance, financial projections, and our ability to successfully develop and commercialize our product candidates. Forward-looking statements in this release represent our beliefs and assumptions only as of the date hereof, and we expressly disclaim any obligation to update these statements as new information becomes available, except as required by law.

Editor's Note: The University of Pennsylvania (Penn) holds equity interests in Verismo's parent company HLB Innovation and has licensed certain Penn-owned intellectual property to Verismo. Penn's Perelman School of Medicine receives funding for research and development of certain Verismo products. Penn may receive future financial benefits related to the licensing of certain Penn intellectual property to Verismo.

Media Contact, Verismo Therapeutics 
Pavel Aprelev, PhD
Pavel.Aprelev@verismotherapeutics.com

Media Contact, IFLI
Laura DiCaprio
McDougall Communications
laura@mcdougallpr.com
+1 (585) 434-2153

IFLI (PRNewsfoto/Verismo Therapeutics)

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SOURCE Verismo Therapeutics